Microbicides Acceptability Among Sexually Active Young Women

This study has been completed.

Sponsor:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00490152

First Posted: June 22, 2007

Last Update Posted: February 28, 2017

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Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.

Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.

Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.

Other Names:

HEC Placebo Gel

HEC Gel

Detailed Description:

ATN 062 will take place in parallel to another study, MTN 004, "Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women." ATN 062 will use quantitative and qualitative research methods. The quantitative method will consist of a computerized diary used by participants during the 14 days of the gel trial of MTN 004. The qualitative methods will include email messages sent by participants to a research assistant as a supplement to the diaries, as well as in-depth interviews through teleconferences to contextualize the recorded events. All study activities will be timed to coincide with those of MTN 004

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 24 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

HIV-negative women ages 18 to 24 years old who are non-pregnant, sexually active and enrolled in MTN 004 will be offered the option to enroll in ATN 062. Approximately half of the participants will be recruited in San Juan, PR, and the other half in Tampa, FL.

Criteria

Inclusion Criteria:

Currently enrolled in MTN 004.

Willing and able to provide written informed consent for ATN 062.

Willing to participate as required by protocol, including completion of all assessments and follow-ups.

Exclusion Criteria:

Refuses to have teleconferences audio recorded.

Any social or medical condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490152

Locations

United States, Florida

University of South Florida College of Medicine

Tampa, Florida, United States, 33606

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Puerto Rico

University Pediatric Hospital

San Juan, Puerto Rico, 00936

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators

Study Chair:

Alex Carballo-Diéguez, PhD

HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University